PAIN AFTER CARDIAC ARREST AND RESUSCITATION

NCT07564778 | Recruiting

• 1 other identifier: STEPCARE_PAINCARE
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 3

Brief Summary

The PAINCARE study is a substudy of the international STEPCARE trial, which investigates sedation, analgesia, and outcomes after cardiac arrest. The purpose of PAINCARE is to examine how pain, its assessment, and its treatment are related to delirium, resource use, and long-term outcomes in patients who have been resuscitated after cardiac arrest and treated in the intensive care unit (ICU). Pain is frequent in critically ill patients but often underrecognized and undertreated, particularly among those who are sedated or mechanically ventilated. After cardiac arrest, patients may experience pain caused by chest compressions, invasive procedures, or prolonged immobilization. Despite this, little is known about how pain is assessed and managed in this group or how pain and analgesic treatment influence clinical recovery and patient-reported outcomes. PAINCARE will collect detailed information on pain intensity, pain assessments, and analgesic use in parallel with data on sedation, delirium, and recovery. Data will be obtained through the same electronic case report form (eCRF) and procedures as the main STEPCARE trial. The main question PAINCARE aims to answer is: How are pain and pain management related to delirium, ICU resource use, and long-term outcomes in patients who have survived cardiac arrest? By improving understanding of pain and its management in this vulnerable patient group, the study seeks to inform better pain assessment and treatment strategies in the ICU, with the ultimate goal of improving comfort, reducing complications such as delirium, and supporting better recovery for survivors of cardiac arrest.

Conditions

Pain; Out of Hospital Cardiac Arrest

Keywords

Adult; human; out of hospital cardiac arrest; Chest compressions; Cardio pulmonary resuscitation; pain; delirium; quality of life; Mechanical ventiltion; Intensive Care length of stay

Outcome Measures

Primary Outcomes (1)

• Restricted mean time (hours) in moderate/severe pain while alive and in ICU by 168 h

  The primary outcome is the restricted mean time (hours) that patients spend in moderate or severe pain during the first 168 hours (7 days) of ICU care after cardiac arrest, while alive and in the ICU. Pain intensity is assessed at regular intervals using validated behavioral or self-report scales: the Behavioral Pain Scale (BPS, range 3-12; \>5 = moderate/severe pain), the Critical Care Pain Observation Tool (CPOT, range 0-8; \>2 = moderate/severe pain), or the Numeric Rating Scale (NRS, 0-10; \>3 = moderate/severe pain). Each assessment reflects the highest observed pain since the previous timepoint, allowing calculation of total time spent in moderate/severe pain across the first 7 days.

  From enrollment to 168 hours

Secondary Outcomes (8)

• Proportion of time spent in moderate or severe pain during the first 168 hours

  Enrollment to 168 hours

• Delirium-free days alive in the ICU by 168 hours

  Enrollment to 168 hours

• Proportion of patients achieving a mobility level greater than 1

  Enrollment to 168 hours

• Hours alive and free of invasive ventilation by day 30

  Enrollment to day 30

• ICU-free days alive at day 30

  Enrollment to day 30

Study Arms (1)

Comatose out-of hospital cardiac arrest patients

Adult(≥18 years), Comatose(Not following verbal command), included in the Sedation, TEmperature and Pressure after Cardiac Arrest and REsuscitation(STEPCARE) trial (NCT05706194) and enrolled at an ICU participating in the PAINCARE substudy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients enrolled in the STEPCARE trial at centers participating in the PAINCARE substudy

You may qualify if:

• Out-of-hospital Cardiac Arrest
• Adult(≥18years)
• Spontaneous circulation without chest compressions ≥20 min
• Comatose(Does not obey commands)
• Enrolled within 4h after ROSC

You may not qualify if:

• Restrictions or limitations of care
• On ECMO prior to randomization
• Pregnancy
• Previously randomized in the STEPCARE trial
• Trauma or hemhorrage as presumed cause of arrest
• Suspected or confirmed intracranial hemhorrage

Sponsors & Collaborators

• Region Skane: lead

Study Sites (3)

Dep. of Intensive Care Halmstad Lasarett

Halmstad, Sweden

RECRUITING

Department of Intensive Care, Skåne University Hospital

Malmö, 20205, Sweden

RECRUITING

Dep. of Intensive Care, Norrlands Universitets Sjukhus

Umeå, Sweden

RECRUITING

Related Publications (3)

• Niemela VH, Reinikainen M, Nielsen N, Bass F, Young P, Lilja G, Dankiewicz J, Hammond N, Hastbacka J, Levin H, Moseby-Knappe M, Saxena M, Tiainen M, Ceric A, Holgersson J, Kamp CB, Tirkkonen J, Oksanen T, Kaakinen T, Bendel S, During J, Lybeck A, Johnsson J, Unden J, Lundin A, Kahlin J, Grip J, Lotman E, Romundstad L, Seidel P, Stammet P, Graf T, Mengel A, Leithner C, Nee J, Druwe P, Ameloot K, Wise MP, McGuigan PJ, White J, Govier M, Maccaroni M, Ostermann M, Hopkins P, Proudfoot A, Handslip R, Pogson D, Jackson P, Nichol A, Haenggi M, Hilty MP, Iten M, Schrag C, Nafi M, Joannidis M, Robba C, Pellis T, Belohlavek J, Rob D, Arabi Y, Buabbas S, Yew Woon C, Aneman A, Stewart A, Arnott C, Ramanan M, Panwar R, Delaney A, Reade M, Venkatesh B, Navarra L, Crichton B, Knight D, Williams A, Friberg H, Cronberg T, Jakobsen JC, Skrifvars MB. Higher versus lower mean arterial blood pressure after cardiac arrest and resuscitation (MAP-CARE): A protocol for a randomized clinical trial. Acta Anaesthesiol Scand. 2025 Jul;69(6):e70040. doi: 10.1111/aas.70040.

  PMID: 40392139 RESULT

• Holgersson J, Niemela V, Skrifvars MB, Kamp-Jorgensen C, Saxena M, Young P, Bass F, Dankiewicz J, Hammond N, Hastbacka J, Levin H, Lilja G, Moseby-Knappe M, Tiainen M, Reinikainen M, Ceric A, During J, Lybeck A, Rodriguez-Santos D, Johnsson J, Unden J, Lundin A, Kahlin J, Grip J, Rosell J, Lotman EM, Navarra L, Crichton B, Knight D, Williams A, Romundstad L, Seidel P, Stammet P, Graf T, Mengel A, Leithner C, Nee J, Druwe P, Ameloot K, Wise M, Riddel J, Ahmed M, Buckel M, Mc Guigan P, Maharaj R, Wyncoll D, Thomas M, White J, Keeble TR, Pogson D, Nichol A, Haenggi M, Hilty MP, Iten M, Schrag C, Nafi M, Joannidis M, Robba C, Pellis T, Belohlavek J, Smid O, Rob D, Arabi Y, Buabbas S, Yew Woon C, Aneman A, Stewart A, Bernard S, Palmer-Simpson C, Simpson N, Ramanan M, Reade M, Delaney A, Venkatesh B, Tirkkonen J, Oksanen T, Kaakinen T, Bendel S, Friberg H, Cronberg T, Jakobsen J, Nielsen N. Fever management with or without a temperature control device after out-of-hospital cardiac arrest and resuscitation (TEMP-CARE): A study protocol for a randomized clinical trial. Acta Anaesthesiol Scand. 2025 May;69(5):e70034. doi: 10.1111/aas.70034.

  PMID: 40222389 RESULT

• Ceric A, Dankiewicz J, Hastbacka J, Young P, Niemela VH, Bass F, Skrifvars MB, Hammond N, Saxena M, Levin H, Lilja G, Moseby-Knappe M, Tiainen M, Reinikainen M, Holgersson J, Kamp CB, Wise MP, McGuigan PJ, White J, Sweet K, Keeble TR, Glover G, Hopkins P, Remmington C, Cole JM, Gorgoraptis N, Pogson DG, Jackson P, During J, Lybeck A, Johnsson J, Unden J, Lundin A, Kahlin J, Grip J, Lotman EM, Romundstad L, Seidel P, Stammet P, Graf T, Mengel A, Leithner C, Nee J, Druwe P, Ameloot K, Nichol A, Haenggi M, Hilty MP, Iten M, Schrag C, Nafi M, Joannidis M, Robba C, Pellis T, Belohlavek J, Rob D, Arabi YM, Buabbas S, Yew Woon C, Aneman A, Stewart A, Reade M, Delcourt C, Delaney A, Ramanan M, Venkatesh B, Navarra L, Crichton B, Williams A, Knight D, Tirkkonen J, Oksanen T, Kaakinen T, Bendel S, Friberg H, Cronberg T, Jakobsen JC, Nielsen N. Continuous deep sedation versus minimal sedation after cardiac arrest and resuscitation (SED-CARE): A protocol for a randomized clinical trial. Acta Anaesthesiol Scand. 2025 May;69(5):e70022. doi: 10.1111/aas.70022.

  PMID: 40178107 RESULT

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest; Pain; Delirium

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Confusion; Neurobehavioral Manifestations; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Joachim P Düring, MD, PhD

CONTACT

+46705917599; joachim.during@med.lu.se

Mia H Hylén, RN, PhD

CONTACT

+46708277226; mia.hylen@skane.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 4, 2026
• Study Start: October 15, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

SE (3)